OTC ORAL ANTISEPTIC FINAL FORMULATION TESTING GUIDELINES PROPOSED BY FDA
This article was originally published in The Tan Sheet
Executive Summary
OTC ORAL ANTISEPTIC FINAL FORMULATION TESTING GUIDELINES PROPOSED BY FDA in a Feb. 9 tentative final monograph. The agency noted that it is offering procedures for testing the final formulations of such products because "final formulation of an oral antiseptic drug product can affect the effectiveness of the active ingredient." The guidelines, according to FDA, are based on the in vitro effectiveness testing procedures recommended by the OTC Oral Cavity Drag Products Review Panel and the testing procedures proposed by the agency in the OTC first aid antiseptic drugs tentative final monograph.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning